Approval Purgatory: 23andMe, the FDA, and Restrictions on Consumer Agency


Last Month, genetic testing company 23andMe announced that it’s back to business as usual, nearly two years after the FDA ordered the company to remove its health results from the market. Many are celebrating the return as a “triumph” and illustration of how innovation, coupled with a capable CEO like 23andMe’s Anne Wojcicki, can overcome regulatory hurdles.

Let’s not get carried away though. The product 23andMe now markets is a far cry from what it once offered. Instead of providing consumers interpretations of their susceptibility to various diseases, health results are limited to carrier status for diseases that can be passed on to progeny. While significant, this is a much less substantial service. As The New York Times explains, “whether that information, which is of most interest to people planning to have babies, will be compelling is unclear, and there are separate carrier tests available through doctors from other laboratories.”

In the meantime, the fact remains: when the FDA first ordered 23andMe to stop marketing its full Personal Genome Service (PGS), it exercised remarkably poor judgment. It also deprived consumers of agency over their health.

23andMe’s PGS would have seemed like science fiction only ten years ago: consumers spit into a tube, place the sealed tube in a box, mail the box to 23andMe for testing, and presto! – an online account detailing information about their ancestry and health, including genetic predisposition toward having, developing, or carrying a number of diseases.

But just before Thanksgiving 2013, the FDA demanded that the company stop marketing its PGS, insisting that it was subject to the agency’s “premarket approval” and “marketing authorization.” It took one year for 23andMe’s first test to obtain FDA approval – three, if you start the clock at 23andMe’s first premarket notification submission.

This interminable wait harmed consumers who would otherwise have information about their potential health risks and the ability to act on this information. Consumers who purchased the product before the FDA’s letter enjoy 23andMe’s full offering of health-related results, which they can use to start informed conversations with medical professionals. But as long as the PGS is stuck in FDA approval purgatory, newer customers cannot access their personal health information and seek medical guidance about potential health risks. They have less knowledge of, and agency over, their own health.

The FDA’s rationale against 23andMe also demonstrated a flawed understanding of the agency’s mission. The FDA feared that consumers with false positive test results “for breast or ovarian cancer” would “undergo a prophylactic surgery, chemoprevention, intensive screen, or other morbidity-inducing actions.” This concern assumes that, before undergoing such major treatment, consumers would not first want—and have—to be screened by a physician. Not only is this condescending, it is likely impossible.

A 2013 study published in PeerJ controverts the agency’s fears, finding that all surveyed women who used direct-to-consumer genetic tests and identified as having a mutation associated with an increased risk of breast or ovarian cancer consulted a doctor after receiving the results. Those who opted for surgery consulted multiple doctors. The study also showed that these same women were likely to share test results with family members, prompting potentially at-risk people to seek testing.

The FDA also expressed concern that consumers would forgo further testing if they receive a “false negative” for these types of mutation. Here again, the FDA assumed the worst about consumers. The agency’s role is not to limit choice because it thinks consumers cannot make good choices for themselves, but to ensure that the products themselves are safe.

The primary objective of FDA medical device approval is to determine whether the benefits provided by the device outweigh its potential risks. PGS data should undergo the rigor of scientific review, so long as there is compelling evidence that it may be harmful. But 23andMe has consistently demonstrated that the benefits of PGS are numerous and the risks are unsubstantiated.

Although permission to release carrier status information is a big step for 23andMe, and helpful with regards to family planning and risks to potential offspring, it does not help those who are unknowingly at risk for illnesses that can be managed.

Wojcicki says she’s optimistic that the FDA will eventually approve 23andMe’s more ambitious PGS product. When that day does finally arrive, it will be great news for anyone who wants to have more control over his or her health.

It’s a shame the FDA’s paternalism has delayed the moment for two years and counting.


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Kyle Burgess is the co-founder of two social enterprises and has worked in strategy, communications, and program management for a decade. Kyle received her Master’s degree in International Relations & Economics from the Johns Hopkins School of Advanced International Studies (SAIS) and her Bachelor's degree in Political Science from American University.


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